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Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia

Primary Purpose

Gastroparesis, Dyspepsia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gastric emptying breath test
Stomach ultrasound
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroparesis

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Able to complete the Pediatric Cardinal Symptoms Questionnaire
  • Both parent and child must be able to speak and understand English or Spanish

Exclusion Criteria:

  • Have global developmental delay, autism disorder, or psychosis
  • Are nonverbal and/or illiterate
  • Lack fluency in English or Spanish
  • Have other GI comorbidities such as inflammatory bowel disease, celiac disease, eosinophilic esophagitis, peptic ulcer disease, GI malignancy, or gastroesophageal reflux disease responsive to medications (medical records will be reviewed to detect these exclusions)
  • Have a history of surgical procedures that could have potentially affected their GI tract anatomy, such as fundoplication or Ladd's procedure.
  • Healthy child presenting to their well child care visit must not report a history of dyspepsia, have a history of any gastrointestinal disease, or be taking any medication that can disturb the GI tract motility.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Gastroparesis

    Dyspepsia

    Healthy Controls

    Arm Description

    Participants in this group are children diagnosed with gastroparesis per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.

    Participants in this group are children diagnosed with functional dyspepsia per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.

    Participants in this group are children that do not have gastroparesis, functional dyspepsia, or any other gastroenterology condition. Participants will be getting an ultrasound once.

    Outcomes

    Primary Outcome Measures

    Gastric emptying rate
    As measured by the spirulina breath test

    Secondary Outcome Measures

    Percentage of food retained in the stomach
    Fundic accommodation will be reported as the percentage of food retained in the fundus using an ultrasound before and after meal ingestion.
    Pediatric Cardinal Symptoms Questionnaire Scores
    The pediatric symptoms questionnaires has a total score ranging from 0-600. Higher score means worse symptoms.

    Full Information

    First Posted
    August 23, 2021
    Last Updated
    October 6, 2022
    Sponsor
    University of Miami
    Collaborators
    American Neurogastroenterology and Motility Society
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05055336
    Brief Title
    Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia
    Official Title
    Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia: Toward Individualized Care in Functional Abdominal Pain Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Principal Investigator left the institution.
    Study Start Date
    May 1, 2022 (Anticipated)
    Primary Completion Date
    April 1, 2023 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Miami
    Collaborators
    American Neurogastroenterology and Motility Society

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this research is to further study the relationship between gastroparesis (GP) (a condition in which the stomach cannot empty itself of food in a normal fashion) and functional dyspepsia (FD) (frequent symptoms of indigestion that have no obvious cause).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroparesis, Dyspepsia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gastroparesis
    Arm Type
    Experimental
    Arm Description
    Participants in this group are children diagnosed with gastroparesis per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.
    Arm Title
    Dyspepsia
    Arm Type
    Experimental
    Arm Description
    Participants in this group are children diagnosed with functional dyspepsia per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.
    Arm Title
    Healthy Controls
    Arm Type
    Experimental
    Arm Description
    Participants in this group are children that do not have gastroparesis, functional dyspepsia, or any other gastroenterology condition. Participants will be getting an ultrasound once.
    Intervention Type
    Other
    Intervention Name(s)
    Gastric emptying breath test
    Intervention Description
    The gastric emptying breath test is used to diagnose gastroparesis. Participants ingest spirulina in a meal and samples are taken every 45 minutes for 4 hours.
    Intervention Type
    Other
    Intervention Name(s)
    Stomach ultrasound
    Intervention Description
    Ultrasound of the fundus of the stomach will be done immediately after ingestion of the test meal, at 15 minutes, and at 30 minutes.
    Primary Outcome Measure Information:
    Title
    Gastric emptying rate
    Description
    As measured by the spirulina breath test
    Time Frame
    up to 6 months
    Secondary Outcome Measure Information:
    Title
    Percentage of food retained in the stomach
    Description
    Fundic accommodation will be reported as the percentage of food retained in the fundus using an ultrasound before and after meal ingestion.
    Time Frame
    Day 1
    Title
    Pediatric Cardinal Symptoms Questionnaire Scores
    Description
    The pediatric symptoms questionnaires has a total score ranging from 0-600. Higher score means worse symptoms.
    Time Frame
    Up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Able to complete the Pediatric Cardinal Symptoms Questionnaire Both parent and child must be able to speak and understand English or Spanish Exclusion Criteria: Have global developmental delay, autism disorder, or psychosis Are nonverbal and/or illiterate Lack fluency in English or Spanish Have other GI comorbidities such as inflammatory bowel disease, celiac disease, eosinophilic esophagitis, peptic ulcer disease, GI malignancy, or gastroesophageal reflux disease responsive to medications (medical records will be reviewed to detect these exclusions) Have a history of surgical procedures that could have potentially affected their GI tract anatomy, such as fundoplication or Ladd's procedure. Healthy child presenting to their well child care visit must not report a history of dyspepsia, have a history of any gastrointestinal disease, or be taking any medication that can disturb the GI tract motility.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liz Febo-Rodriguez, MD
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia

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